May 2022

· 5 min read

Pharma Pipeline at All-Time High

More than 20,000 products are under active development. Find out more about the latest report and what else is happening in NSF’s May 2022 news update.
A Multi-channel pipette loading biological samples for test - Pharma Development Pipeline at All-Time High | NSF

The pharma industry’s development pipeline has reached a new high of over 20,000 products under active development.

Data from Informa’s “Pharma R&D Annual Review 2022” shows that 20,109 products were under active development at the end of January 2022. This is an increase from 18,582 products at the same time in 2021.

The size of the R&D pipeline has seen almost uninterrupted growth since the turn of the century, with just under 6,000 projects under active development in January 2021.

Novartis AG accounts for 213 new products, while Roche, Takeda, BMS and Pfizer account for almost 1,000 new products.

China’s growing pharmaceutical market has seen two Chinese-headquartered companies entering the top-25 list for the first time. Shanghai Fosun Pharmaceuticals and Jiangsu Hengrui Pharmaceuticals have 168 new products at the pipeline stage.

According to the report, there are 5,416 companies with new drugs in development. You can download the report.

Points To Consider for Clinical Trials and Adaptive Design

Our colleagues at Amarex have created a video that looks at the issues companies need to consider when designing a clinical trial for a new product.

New ICH Draft Guidelines Make Switching Analytical Methods Easier

The International Council for Harmonization (ICH) has issued two draft guidelines to make it easier for manufacturers to switch analytical methods for testing medicines post-approval. The guidelines aim to promote a more robust analytical process.

The Q2 document covers the validation principles for using near-infrared-based (NIR-based) analysis and Raman spectroscopy. The Q14 guideline aims to harmonize the scientific approach for analytical procedures development.

The guidelines intend to complement ICH Q18 with Q12 guidelines and the ongoing continuous manufacturing guidelines in ICH Q13.

European Pharmacopoeia Debates Replacing Oxidizable Substance Test

The experts at the European Pharmacopoeia (Ph. Eur.) are considering replacing the test for oxidizable substances with the test for total organic carbon (TOC) in the “Tests” section of the “Sterilised water for injections” part of the monograph on “Water for injections (0169).”

This change has been discussed with other pharmacopeias (U.S. Pharmacopeia, Japanese Pharmacopoeia) and is already implemented in one of them.

The experts of the Ph. Eur. would like to gather information from manufacturers before the official consultation phase to help ensure that the method and acceptance criteria envisaged in the discussions with partner pharmacopeias would be appropriate and feasible for European manufacturers of sterilized water in containers.

Meet the NSF Pharma Team in May

NSF’s pharma and biotech consulting and training team will be attending Interphex New York from May 24-26.

Varun Venkatchalum, Brian Cleary and colleagues will be at stand 2826 at the Javits Center, meeting clients and attendees over the event’s three days.

Pop by stand 2826 to meet with the team, have your questions answered and find out more about how NSF is helping the world’s largest and most dynamic health sciences companies.

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